Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States are more likely to be hospitalized with flu, as well as less likely to be vaccinated against flu, according to a new CDC Vital Signs report. CDC is working to increase flu vaccination rates by using proven strategies to raise awareness of how serious flu can be and break down barriers to vaccination.
The Vital Signs report looked at flu hospitalization rates from 20092022 and flu vaccination coverage from 20102022 by race and ethnicity, from two data sources, the Influenza-Associated Hospitalization Network (FluSurv-NET) and Behavioral Risk Factor Surveillance System (BRFSS).
Flu vaccines are the best way to protect against flu and its potentially serious complications. Improving access to and trust in flu vaccines among people is critical to help reduce inequities."
Debra Houry, M.D., M.P.H. CDC Acting Principal Deputy Director
Flu vaccination coverage has been consistently lower among Black, Hispanic, and AI/AN adults since 2010. During the 20212022 season, flu vaccination coverage was 54% among White and Asian adults, 42% among Black adults, 38% among Hispanic adults, and 41% among AI/AN adults.
Black, Hispanic, and AI/AN adults were hospitalized with flu at higher rates than White adults during most seasons from 2009 to 2022.* Compared to White adults, hospitalization rates were nearly:
There are many reasons for disparities in severe outcomes of flu, including lack of access to health care and insurance, missed opportunities to vaccinate, and misinformation and distrust that contribute to lower levels of confidence in vaccines. People from certain racial and ethnic minority groups have higher rates of asthma, diabetes, obesity, and other chronic conditions. These increase the risk for serious flu complications. Racism and prejudice also are known to worsen inequalities.
Over the past two years, CDC began programs to address barriers to flu vaccination and raise awareness about its importance, specifically among people from racial and ethnic minority groups. These include the Partnering for Vaccine Equity (P4VE) program and a targeted, national flu vaccination campaign. These programs use proven actions to help increase vaccination among people from racial and ethnic minority communities.
Health care providers, state and federal officials, and individuals can work together to fight flu by taking steps to increase vaccine uptake in everyone, including people from racial and ethnic minority groups.
For more information about this report, go to www.cdc.gov/vitalsigns.
Waveny/Visiting Nurse and Hospice is offering drive-through flu vaccine clinics at its 22 Danbury Rd. location on Thursday, Oct. 26, and Thursday, Nov. 2.
The clinics are scheduled to run from 2-4:30 p.m. with no need to get out of the car. A registered nurse will greet each car, making it easy for someone with mobility issues.
The vaccines administered are regular quadrivalent and adjuvanted doses for people over 65 years of age.
Waveny/Visiting Nurse and Hospice is also offering a homebound flu vaccine program for people who qualify. For more information, reach out to Christine Burns at 203.762.8958, ext. 312 for more details.
Waveny/Visiting Nurse will bill directly to Medicare, Aetna Managed Care Medicare and Anthem Blue Cross/Blue Shield.
For more information on the clinics, visit the Visiting Nurse website.
It wouldnt be an overstatement to call the HPV vaccine a medical miracle.
Its like the gift that keeps giving, says Mark Jit, a professor of vaccine epidemiology at the London School of Hygiene & Tropical Medicine. Not only is it the sole vaccine that can prevent cancer, we discover its an even better vaccine as time goes on, he says.
Since its development and rollout in the mid-2010s, the HPV vaccines prowess at heeding off cervical cancer rates has been remarkable. Over an 11-year period in the United Kingdom, cases of cervical cancer fell by 87 percent among those who received the vaccine compared to those who didnt. Its conceivable that one day, a whole form of cancer could be effectively eliminated.
And the vaccines dont just protect against cervical cancer. They can also prevent head and neck, vaginal, anal, and penile cancer, as well as protecting against genital warts in both genders. But theres the rub: Although these vaccines protect against cancers that affect both men and women, boys and men arent offered the vaccine in two-thirds of countries where they are available. In those places, half the people who could benefit are missing out on a potentially life-saving intervention. But thats starting to change.
When the rollout of HPV vaccines was first gearing upand their price was still highit made sense to target the most at-risk group, says Jit, that being girls between the ages of 9 and 14. But in the intervening decade or so, the vaccines have dropped significantly in price. Over the same period, research showcasing the benefits of gender-neutral HPV vaccine campaigns has compounded. From a social justice and equality point of view, it makes sense to vaccinate men and women, says Kit Yates, a mathematical biologist at the University of Bath. Failure to do so means men are left at risk, and this places the onus on women to protect men from HPV, rather than sharing the burden.
A barrier to wider rollout in recent years has been uneven supply: as eligible groups expanded, demand shot up. The makers of the vaccines couldnt keep up, and there was a major squeeze, meaning many low-income countries had to go without. But supply has started to ramp up again, and Indiathe worlds largest vaccine producerdebuted its own home-grown vaccine last year.
New research has also shown that just one dose offers sufficient protection, meaning the usual two-dose regime can be halved and double the people can be included in national rollouts. Now is the time we can start asking, actually, are there other groups that should be vaccinated? says Jit.
A Very Common Problem
HPV, or human papillomavirus, is the everyman STI. Between 80 and 90 percent of people will acquire it at some point in their lives, typically through skin-to-skin contact. Odds are that you, reader, will probably pick up the virusif you havent already. Luckily, for most carriers it wont have an impact; you can be asymptomatic for your whole life.
But for a small chunk of carriers, HPV can lead to potentially fatal cases of cancer; of the around 200 types of HPV, scores are cancer-causing. HPV becomes cancerous by sneaking into the body and burrowing itself into cells, where it photocopies itself. Most infections wont take root, and your body will boot them out within a year or two. But some persistent infections can linger on, changing normal cells to abnormal cells, which can lead to cancer if untreated.
Duke researchers have successfully developed a pan-coronavirus vaccine, effective against three deadly strains, with proven efficacy in mouse studies. This advancement paves the way for potential human trials and marks significant progress towards a universal coronavirus vaccine, addressing a critical global health need.
A promising vaccine targeting three lethal coronaviruses has proven effective in preliminary mouse trials, underscoring the potential for a universal coronavirus vaccine.
The research, conducted by experts at the Duke Human Vaccine Institute, was recently published in the journal Cell Reports. This innovative nanoparticle vaccine builds upon a former version that shielded mice and primates from various strains of SARS-CoV-2, the culprit behind COVID-19.
In this study, the vaccine protected mice from SARS-CoV-1, another form of SARS coronavirus that can infect humans, and a MERS coronavirus that has led to periodic, deadly outbreaks around the world.
We are making important progress toward a broadly protective coronavirus vaccine, said senior authorKevin O. Saunders, Ph.D., associate director of theDuke Human Vaccine Institute. These are pathogens that cause or have the potential to cause significant human infections and loss of life, and a single vaccine that provides protection could slow down or even prevent another pandemic.
Saunders and colleagues built the tri-valent vaccine using a nanoparticle loaded with a key fragment called a receptor binding domain from each of the coronaviruses. The fragment a docking site on the virus that enables it to infiltrate the bodys cells provides enough information for immune cells to build an effective response against actual coronaviruses that enter the body.
In earlier studies in mice and primates, the researchers demonstrated that an earlier iteration of the nanoparticle vaccine was effective against multiple SARS-CoV-2 variants. Human tests are planned next year for a version that carries immunogens to different SARS-CoV-2 strains, including those that have dominated since the original outbreak in late 2019.
The current work expands the components of the vaccine to include an additional SARS-related virus and MERS virus. In lab studies, as well as in mice, the researchers found that the vaccine candidate generated inhibitory immune molecules called antibodies against all three pathogenic human coronavirus types.
Importantly, vaccinated mice did not grow sick when challenged with either SARS-like or MERS-like viruses.
This study demonstrates proof-of-concept that a single vaccine that protects against both MERS and SARS viruses is an achievable goal, Saunders said. Given that one MERS and two SARS viruses have infected humans in the last two decades, the development of universal coronavirus vaccines is a global health priority.
Reference: Vaccine-mediated protection against Merbecovirus and Sarbecovirus challenge in mice by David R. Martinez, Alexandra Schfer, Tyler D. Gavitt, Michael L. Mallory, Esther Lee, Nicholas J. Catanzaro, Haiyan Chen, Kendra Gully, Trevor Scobey, Pooja Korategere, Alecia Brown, Lena Smith, Robert Parks, Maggie Barr, Amanda Newman, Cindy Bowman, John M. Powers, Erik J. Soderblom, Katayoun Mansouri, Robert J. Edwards, Ralph S. Baric, Barton F. Haynes and Kevin O. Saunders, 18 October 2023,Cell Reports. DOI: 10.1016/j.celrep.2023.113248
In addition to Saunders, study authors include lead author David R. Martinez, who is now at Yale School of Medicine, and Alexandra Schafer, Tyler D. Gavitt, Michael L. Mallory, Esther Lee, Nicholas J. Catanzaro, Haiyan Chen, Kendra Gully, Trevor Scobey, Pooja Korategere, Alecia Brown, Lena Smith, Rob Parks, Maggie Barr, Amanda Newman, Cindy Bowman, John M. Powers, Erik J. Soderblom, Katayoun Mansouri, Robert J. Edwards, Ralph S. Baric, and Barton F. Haynes.
The study received funding support from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (U54 CA260543, P01 AI158571).
Shares of Pfizer are falling before the opening bell as the company cut its full-year outlook, citing declining sales of its COVID-19-related products
By
MICHELLE CHAPMAN AP Business Writer
October 16, 2023, 8:21 AM ET
2 min read
Shares of Pfizer are in retreat on the first day of trading after the drug company said sales of its COVID-19 vaccine and its coronavirus treatment are weaker than it had expected and cut revenue projections by $9 billion for the year.
Falling sales of both clipped sales in the second quarter, but Pfizer said in August that it expected a rebound in the second half of 2023.
Shares of Pfizer slipped more than 1% before the opening bell Monday and Moderna, which is heavily reliant on the competing vaccine it makes, slid nearly 5%.
Pfizer said Friday that global usage of Paxlovid is trending slightly above last year, but that it's still below expectations.
The fall vaccination period just began and the New York City drugmaker said that it's too soon to get a handle on vaccination rates for the year.
Full-year revenue for Paxlovid and Comirnaty is expected to be approximately $12.5 billion, short $9 billion of what it had expected.
Pfizer is lowering its full-year revenue expectations for Paxlovid by approximately $7 billion. That number also accounts for delayed commercialization of the product, which was pushed to January 2024 from the company's previous expectation of commercialization in the second half of this year. Pfizer is also lowering its 2023 revenue expectations for Comirnaty by approximately $2 billion due to lower-than-expected vaccination rates.
Pfizer Inc. now foresees 2023 revenue in a range of $58 billion to $61 billion, down from its prior forecast for $67 billion to $70 billion. It now projects full-year adjusted earnings between $1.45 and $1.65 per share due to lower-than-anticipated revenue for COVID-19-related products and inventory write-offs.
That is short of the full-year revenue of $63.61 billion and earnings of $2.77 per share that Wall Street was expecting, and far short of the company's previous projections of per-share earning between $3.25 and $3.45.
JPMorgan said the company's update solves an ongoing U.S. Paxlovid inventory debate and it anticipates the company's bigger-than-expected cuts to its sales projections will help put a floor under per-share earnings expectations for next year.
A vaccine designed to protect against three different deadly coronaviruses shows success in mouse studies, demonstrating the viability of a pan-coronavirus vaccine developed by researchers at the Duke Human Vaccine Institute.
Publishing in the journal Cell Reports, the single nanoparticle vaccine included components of a previous vaccine that was shown to protect mice and primates against multiple variants of SARS-CoV-2, which is the virus that causes COVID-19. In this study, the vaccine protected mice from SARS-CoV-1, another form of SARS coronavirus that can infect humans, and a MERS coronavirus that has led to periodic, deadly outbreaks around the world.
"We are making important progress toward a broadly protective coronavirus vaccine," said senior author Kevin O. Saunders, Ph.D., associate director of the Duke Human Vaccine Institute. "These are pathogens that cause or have the potential to cause significant human infections and loss of life, and a single vaccine that provides protection could slow down or even prevent another pandemic."
Saunders and colleagues built the tri-valent vaccine using a nanoparticle loaded with a key fragment called a receptor binding domain from each of the coronaviruses. The fragment -- a docking site on the virus that enables it to infiltrate the body's cells -- provides enough information for immune cells to build an effective response against actual coronaviruses that enter the body.
In earlier studies in mice and primates, the researchers demonstrated that an earlier iteration of the nanoparticle vaccine was effective against multiple SARS-CoV-2 variants. Human tests are planned next year for a version that carries immunogens to different SARS-CoV-2 strains, including those that have dominated since the original outbreak in late 2019.
The current work expands the components of the vaccine to include an additional SARS-related virus and MERS virus. In lab studies, as well as in mice, the researchers found that the vaccine candidate generated inhibitory immune molecules called antibodies against all three pathogenic human coronavirus types.
Importantly, vaccinated mice did not grow sick when challenged with either SARS-like or MERS-like viruses.
"This study demonstrates proof-of-concept that a single vaccine that protects against both MERS and SARS viruses is an achievable goal," Saunders said. "Given that one MERS and two SARS viruses have infected humans in the last two decades, the development of universal coronavirus vaccines is a global health priority."
In addition to Saunders, study authors include lead author David R. Martinez, who is now at Yale School of Medicine, and Alexandra Schafer, Tyler D. Gavitt, Michael L. Mallory, Esther Lee, Nicholas J. Catanzaro, Haiyan Chen, Kendra Gully, Trevor Scobey, Pooja Korategere, Alecia Brown, Lena Smith, Rob Parks, Maggie Barr, Amanda Newman, Cindy Bowman, John M. Powers, Erik J. Soderblom, Katayoun Mansouri, Robert J. Edwards, Ralph S. Baric, and Barton F. Haynes.
The study received funding support from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (U54 CA260543, P01 AI158571).
Norways 86-year-old King Harald V has tested positive for the coronavirus and has mild symptoms
October 22, 2023, 11:19 AM ET
2 min read
HELSINKI -- Norways 86-year-old King Harald V, who has been in frail health in the past few years, has tested positive for the coronavirus and has mild symptoms, royal officials said on Sunday.
His Majesty the King has been diagnosed with corona and is on sick leave until he is symptom-free. The king has cold symptoms and stays at home, the royal household said in a brief statement.
The Norwegian monarch had also tested positive in March 2022 with mild symptoms. Officials have earlier said Harald had received three COVID-19 vaccine shots but it's not known whether he had received booster shots.
Prime Minister Jonas Gahr Stre wished the king a speedy recovery in a comment to the Norwegian news agency NTB, which said Harald's son and heir to the throne, Crown Prince Haakon, would take over his duties for now.
The aging monarch, who has been seen using crutches in various occasions, has been hospitalized several times in recent years.
In August 2022, he spent three days with a fever at a hospital, and in December the same year, he was again admitted for an infection that required intravenous antibiotics.
In October 2020, the king underwent surgery to replace a heart valve after being hospitalized with breathing difficulties.
Despite health problems, he has been attending major public events in Norway and its Nordic neighbors. In September, Harald attended celebrations in Stockholm marking the 50th anniversary of Swedens King Carl XVI Gustafs accession to the throne.
In May, the monarch, who was released from a hospital just days earlier, appeared on the royal castles balcony in Oslo to salute the thousands of children marching by as the country celebrated its Constitution Day.
The king is Norways head of state but holds no political power, so his duties are ceremonial. Harald ascended to the throne following the death of his father, King Olav, in 1991.
A recent study published in the Journal of Internal Medicine investigates the correlations between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and benign prostatic hyperplasia (BPH).
Study:SARSCoV2 infection correlates with male benign prostatic hyperplasia deterioration. Image Credit:Fotoluminate LLC/ Shutterstock.com
SARS-CoV-2, the causal agent of the coronavirus disease 2019 (COVID-19), can infect extrapulmonary systems. Prostate epithelial cells express both angiotensin-converting enzyme 2 (ACE2) and transmembrane protease serine 2 (TMPRSS2), thus suggesting that SARS-CoV-2 can infect the lower urinary tract in males.
Metabolic syndrome and diabetes mellitus are known risk factors for lower urinary tract symptoms (LUTS) that can impact the prostate. SARS-CoV-2 is known to cause new-onset metabolic complications, which could aggravate LUTS.
BPH can cause urinary tract infections (UTIs), retention of urine (ROU), bladder stones, and hematuria. Like COVID-19, BPH is prevalent among aging males, with an estimated incidence of 80% in adults 70 years of age and older; therefore, COVID-19 patients may be more likely to develop BPH complications. Currently, there is limited evidence on the relationship between COVID-19 and LUTS.
In the present study, researchers explore the correlations between COVID-19 and BPH. Relevant data were retrieved from a patient record database of the Hong Kong Hospital Authority.
Patients on monotherapy with long-acting alpha-1 adrenoreceptor blockers (AARBs) for LUTS in 2021 and 2022 were included. Individuals with a history of urolithiasis or prostate cancer in the past five years or ROU in the past year were excluded.
Subjects with a positive SARS-CoV-2 polymerase chain reaction (PCR) test were included in the COVID-19 group, while those without a positive PCR test were in the control group. The study outcomes included the incidence of BPH complications such as UTI, bacteriuria, hematuria, and ROU, as well as the addition of a 5-alpha reductase inhibitor (5ARI) as a combination therapy for LUTS.
Data on UTI, hematuria, and ROU were based on clinical diagnosis codes in the database, whereas bacteriuria was determined based on positive urine cultures. Propensity scores were calculated using logistic regression, and propensity score matching was performed to adjust/balance potential confounders.
A chi-squared test compared the outcomes between SARS-CoV-2-infected and control groups. Sub-group analyses were performed by age groups and COVID-19 severity.
COVID-19 severity was defined based on medications such as interferons, antivirals, or steroids, hospitalization, intensive care requirement, and intervention, including oxygen therapy or extracorporeal membrane oxygenation.
A total of 192,435 males received AARB monotherapy. After exclusions, there were 176,006 subjects, including 10,651 individuals who tested positive for SARS-CoV-2 infection.
After propensity score matching, 17,986 individuals were retained for analyses, with each group comprising 8,993 subjects. There were significant differences in outcomes between COVID-19 and control groups, with the COVID-19 group associated with a higher incidence of ROU, hematuria, bacteriuria, and 5ARI use.
The incidence of BPH complications was significantly higher across most age groups, except those of a younger age. There were significant differences in the incidence of bacteriuria and ROU in individuals 50 years of age and older, as well as UTI incidence and 5ARI use in patients 60 and older. The incidence of ROU, hematuria, and 5ARI use did not differ by COVID-19 severity.
The incidence of bacteriuria and UTI was significantly lower in patients with asymptomatic or mild COVID-19. Furthermore, in sub-group analyses by COVID-19 supportive medical therapy, hematuria incidence was consistently higher after excluding patients on heparin therapy. Likewise, the incidence of bacteriuria and UTI remained higher after excluding patients prescribed steroids.
SARS-CoV-2 infection was associated with an increased incidence of BPH complications and 5ARI use in males treated for baseline LUTS. The strong positive correlation suggests significant urological manifestations of COVID-19; therefore, it is crucial for urologists and clinicians to be aware of this additional burden.
Sub-group analyses revealed a significantly higher incidence of BPH complications among patients of an older age. Notably, there were no differences in the incidence of hematuria or urinary retention and 5ARI use by COVID-19 severity, thus indicating that these urological manifestations may occur even in patients with mild or asymptomatic COVID-19.
Journal reference:
Study design
In this study, an open-label, non-randomized, two-arm, blank-controlled, investigator-initiated trial was designed to assess the efficacy and safety of the intranasal spray cocktail A8G6 in preventing SARS-CoV-2 infection among close contacts with COVID-19 patients. The clinical trial was conducted at 6 designated quarantine hotels in Yuzhong District, Chongqing, China from November 27, 2022 and was completed on December 12, 2022.
Recruited participants in the treatment group self-administrated a three doses of 0.7mg (140l) A8G6 nasal spray per day for 7 treatment days. The drug was supplied by Chongqing Mingdao Haoyue Biotechnology Co., LTD (Chongqing, China), stored at 28C. In the blank control group, participants did not receive any treatment. After enrollment, SARS-CoV-2 infection was confirmed by a reverse transcription polymerase chain reaction (RT-PCR) test of oropharyngeal swab. During this trial, with the adaption of the anti-COVID-19 policy, not only RT-PCR, but also rapid antigen tests were used to confirm the SARS-CoV-2 infection status.
The trial was carried out in accordance with all applicable national and local regulatory requirements. Data and Safety Monitoring Board of The Second Affiliated Hospital of Chongqing Medical University oversaw trial conduct and documentation. The protocol has been approved by the Chinese clinical test registration center (the world health organization international clinical trials registered organization registered platform (ICTRP), the registration number: ChiCTR2200066416) and the Ethics Committees of The Second Affiliated Hospital of Chongqing Medical University (the approval number: 2022127-1).
During November COVID-19 wave in Chongqing, China, when patients had been diagnosed as COVID-19 with the positive RT-PCR test for SARS-CoV-2 (index cases), their close contacts were immediately transferred to the designated quarantine sites. At 6 quarantine sites in Chongqing, healthy adults aged between 18 to 65 years who had a close contact with index cases within 72hours were enrolled into this study. The maximum time interval between exposure to treatment was 72h. All vaccination status is eligible for inclusion. Exclusion criteria included positive RT-PCR at baseline, nasal discomfort, the use of other COVID-19 antibody drugs and drug-drug interference with participants regular medication (additional details about eligibility criteria were described in the appendix).
All study participants were capable of self-administrating the intranasal spray, recording and recalling clinical signs. All participants were provided and voluntarily signed written informed consent before the study.
At six quarantine sites in the Yuzhong District, Chongqing, site investigation was carried out to screen eligible participants. Eligible participants were given the choice to join the A8G6 treatment group or blank control group. For eligible participants that showed no preference in either group, they were randomly assigned to A8G6 treatment group or blank control group. Oropharyngeal swabs were taken for quantitative and qualitative RT-PCR assessments at baseline prior to treatment and though the treatment period and a follow-up period. Subjects with positive RT-PCR results before treatment were excluded. The SARS-CoV-2 viral load was present by viral genome copies per mL log10 values with the conversion of the open reading frame of 1ab (ORF1ab) and nucleocapsid (N-gene) cycle threshold (Ct) values (RT-PCR was conducted by Yuzhong District Center for Disease Control and Prevention, in Chongqing, China. Conversion of Ct values to viral genome copies was calculated according to the manufacturers instructions of 2019-nCoV viral RNA kit produced by BioPerfectus Technologies, catalog number: JC10223-1N).
Subjects demographic data, health and COVID-19 vaccination status were recorded at the baseline visit (Day 0). The use of nasal spray, rapid antigen tests or RT-PCR test for COVID-19 were recorded every day during the study participation. When participants in both groups were diagnosed with SARS-CoV-2 infection, the related symptoms and symptomatic treatment for COVID-19 were reported until the trial completed. In the treatment group, all participants were requested to self-report and record the adverse events. Due to the relaxation of COVID-19 control and policy starting from December 4, 2022, some participants returned to home for further isolation. The follow-up visits were adjusted to retrospective telephonic visit according to a questionnaire form from that day.
The primary endpoint analysis included all participants in both the treatment and control groups. The primary endpoint was to assess the efficacy of the intranasal spray A8G6 for post-exposure prophylaxis of COVID-19. In this study, we compared the COVID-19 incidence of the close contacts between the A8G6 treatment individuals and the blank-controlled individuals. We also compared the time from enrollment to SARS-CoV-2 infection between the two groups. The secondary efficacy analysis included the quantitative data of SARS-CoV-2 RNA (log10 copies per mL) at baseline of the positive COVID-19 and the time to conversion of SARS-CoV-2 RNA from positive to negative (viral clearance).
Safety endpoints was adverse event types and the incidence rate of adverse events among all participants of the A8G6 treatment group during the study. An adverse effect was defined as any abnormal signs or symptoms and harmful results caused by the study drug.
The sample size in this clinical trial was determined on the basis of statistical power calculations. We proposed greater than 90% power to detect a 20% relative difference between the A8G6 treated and control group at a two-sided alpha level of 0.05 (ie., a 20% prevention efficacy of A8G6). The formula is as follows:
$$n={frac{2pq({Z}_{1-frac{alpha }{2}}+{Z}_{1-beta })}{{delta }^{2}}}^{2}$$
which p is the proportion of participants develop COVID-19 in A8G6 treated group, q is in the control group, is the difference between two group, is two-sided alpha level, and 1- is statistical power. In this clinical trial, we assume that q is 0.1, 20% relative reduction of A8G6 treated group is 0.08. Assuming a dropout rate of 20%, at total of 5160 participants will be recruited.
The primary efficacy endpoints including COVID-19 incidence and time to confirmed SARS-CoV-2 infection. The COVID-19 incidence was analyzed using the KaplanMeier method and log-rank test, and the time to confirmed SARS-CoV-2 infection was analyzed using Wilcoxon rank-sum test. The secondary efficacy endpoints including viral load when confirmed SARS-CoV-2 infection and the time to negative conversion of SARS-CoV-2 determined by RT-PCR. The viral load when confirmed SARS-CoV-2 infection was analyzed using Wilcoxon rank-sum test, negative conversion of SARS-CoV-2 and remission time were conducted using KaplanMeier method and log-rank-test. Safety was assessed in participants in the full analysis set who received A8G6 nasal spray treatment during the 8-day quarantine period.
Database from the Service Platform for COVID-19 Prevention and Control created by Yuzhong District Center for Disease Control and Prevention were authorized for us to use and analyze. Data including demographic and clinical characteristics of the cohorts, endpoints in this clinical trial were collected from an applet of WeChat (a social media platform in China), called Yuzhong Information Exchange. All data were summarized with descriptive statistics (number of subjects (%), median (IQR), meansd). The credible interval for nasal spray was calculated with the use of a beta-binomial model with prior beta (1, 1) adjusted for the treatment duration time. Continuous variables were compared with the MannWhitney U-test, and Categorical variables were conducted using 2 test or Fishers exact test. A P value of <0.05 was considered statistically significant. Statistical analyses were performed using R software, version 3.6.0.
Researchers from Penn's Perelman School of Medicine found that traces of the COVID virus in longterm patients inhibit the development of serotonin.
A new study led by researchers from Penn's Perelman School of Medicine found that a decrease in serotonin levels is linked to the development of prolonged symptoms in individuals with COVID-19.
According to the study, traces of SARS-CoV-2 in the guts of long COVID-19 patients cause inflammation that prevents the development of serotonin, which is critical to recovery.
Patients with long COVID-19 experience long-term symptoms like brain fog or fatigue in the months or years following the initial COVID-19 infection. According to the CDC, nearly 7.5% of Americans who are infected with COVID-19 experience long-term symptoms.
Many aspects of the basic biology underlying long COVID have remained unclear. As a result, we are lacking effective tools for the diagnosis and treatment of the disease, Maayan Levy, Assistant Professor of Microbiology and senior author of the study, said.
The new study found that the remaining virus in patients with long COVID-19 triggers patients immune system to release interferons, proteins that continue to fight the virus. This, in turn, affects patients absorption of the amino acid tryptophan, which is critical to the development of serotonin.
Serotonin, commonly referred to as the happy hormone, is responsible for memory, happiness, body temperature regulation, sleep, sexual behavior, and hunger. A lack of serotonin is correlated with depression, anxiety, mania, and other health conditions.
Because of the study results, researchers are looking into new ways of treating long COVID-19 by examining serotonin. This novel approach marks a breakthrough in developing treatments for long-term symptoms.
Our findings may not only help to untangle some of the mechanisms that contribute to long COVID, but also provide us with biomarkers that can help clinicians diagnose patients and objectively measure their response to individual treatments, Levy said.
Levy previously received the National Institute of Health Directors Award, which is granted to scientists undertaking innovative research with a broader impact on pressing biomedical challenges.
There has been some evidence to suggest that SSRIs could be effective in preventing long COVID, and our research now presents an opportunity for future studies to select specific patients for a trial who exhibit depleted serotonin, and to be able to measure response to treatment, Benjamin Abramoff, Assistant Professor of Clinical Physical Medicine and Rehabilitation and senior author of the study, said.
